Genesys Orthopedics Systems LLC

Genesys Orthopedics Systems LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthosis, Spinal Pedicle Fixation (MNI) (7) Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease (NKB) (7) Orthosis, Spondylolisthesis Spinal Fixation (MNH) (7) Appliance, Fixation, Spinal Intervertebral Body (KWQ) (3)

Premarket Exempt

No

Clear

TiLock - M719ACS10000 Catalog Number : ACS1000

Device Description : Ancillary Outer Case

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

TiLock - M719ACS10010 Catalog Number : ACS1001

Device Description : Ancillary Outer Case Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719ACS10020 Catalog Number : ACS1002

Device Description : Ancillary Inner Tray

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

TiLock - M719ACS10030 Catalog Number : ACS1003

Device Description : 8.5mm MIS Screw Tray

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719ACS10070 Catalog Number : ACS1007

Device Description : TiLock 8.5mm Lock Screw Caddy

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

TiLock - M719ACS10080 Catalog Number : ACS1008

Device Description : TiLock 8.5mm Lock Screw Caddy Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : MNH, MNI, NKB

Prescription Use : Yes

Device Count : 1

TiLock - M719G10000 Catalog Number : G1000

Device Description : TiLock Implant Case

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : NKB, MNI, MNH

Prescription Use : Yes

Device Count : 1

Lumbar Plate - M719G100000 Catalog Number : G10000

Device Description : Lumbar Plate System Outer Case

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Lumbar Plate - M719G100010 Catalog Number : G10001

Device Description : Lumbar Plate System Outer Case Lid

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

Lumbar Plate - M719G100020 Catalog Number : G10002

Device Description : Lumbar Plate System Middle Tray

Device Class : 2

Duns Number: 017921066

Premarket Exempt : No

Product Code : KWQ

Prescription Use : Yes

Device Count : 1

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